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| Aethlon Medical's Hemopurifier device--Courtesy of Aethlon Medical |
Aethlon Medical ($AEMD) has submitted a Humanitarian Use Device (HUD) application to the FDA for its Ebola biofiltration device, a steppingstone toward full marketing clearance for the product.
The FDA's HUD designation is for products that treat or diagnose a condition that affects fewer than 4,000 individuals in the U.S. per year. If the agency accepts Aethlon's application, it can then submit a Humanitarian Device Exemption (HDE) marketing application to the Center for Devices and Radiological Health (CDRH) for marketing review, the company said in a statement.
The submission comes on the heels of more progress for Aethlon, as in January the company snagged FDA approval for a clinical trial of its biofiltration device in patients with the virus. The San Diego, CA-based company's Hemopurifier product filters viruses and toxins from the blood of individuals infected with Ebola, targeting antiviral drug resistance and serving as a first-line defense against the virus.
Aethlon has already charted some promising numbers for its biofiltration device, highlighting data presented in November at the American Society of Nephrology Annual Meeting that found 242 million Ebola viruses were captured with the Hemopurifier during the treatment of a critically ill patient. The treatment also reduced the patient's Ebola viral load from 400,000 virus copies/mL of blood to 1,000 copies/mL of blood with no reported adverse events, the company said in a statement.
But Aethlon is not the only one developing new tools to counter the deadly virus. In September, scientists at Harvard University announced they were working on a dialysis-like device that acts like a human spleen and filters deadly pathogens out of the blood, effectively treating 90 ailments including Ebola, E. coli and HIV. The tool also includes a genetically modified protein that maximizes the body's ability to fight pathogens.
In November, the Bill & Melinda Gates Foundation said it would funnel $5.7 million into new trials of treatments and plasma-based therapy for Ebola. Med tech companies also got in on the effort, with big names like Abbott ($ABT), Becton Dickinson ($BDX) and Welch Allyn donating and equipment and supplies to aid in blood donation and testing.
- read the release